Sep 5, 2023 · Regulatory information

Cantargia expands clinical pipeline and starts treatment in second program, CAN10, for autoimmune diseases

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today announced that the first subject has been treated with the IL1RAP-binding antibody CAN10, developed for treatment of autoimmune/inflammatory diseases. The phase I clinical trial, conducted in Germany, investigates the safety, pharmacokinetics and biomarkers of CAN10 in healthy volunteers and psoriasis patients. A total of 80 subjects may be included in the trial. Initial data from the trial are expected in 2024.

“We are very excited to have started treatment in this phase I study with CAN10. This achievement is a major milestone and Cantargia now has two independent projects in clinical trials. Based on its powerful mechanism of action, CAN10 has potential to be used in the treatment of a large number of diseases, and we look forward to generating key clinical data from this study,” said Göran Forsberg, CEO of Cantargia.

The primary objective of this phase I trial is to investigate the safety and tolerability of CAN10. Further objectives include pharmacokinetics and effects on various immunological or disease-related biomarkers. Initially, single ascending doses will be given intravenously to up to 64 healthy volunteers. A subsequent part of the trial is designed to also generate an early proof-of-concept in up to 16 patients with mild to moderate psoriasis, who will receive multiple injections of CAN10 subcutaneously at two dose levels. Additional trial details will be disclosed on clinicaltrials.gov.

The CAN10 antibody strongly binds IL1RAP and simultaneously blocks the function of the signaling molecules IL-1, IL-33 and IL-36, which play key roles in several autoimmune and inflammatory diseases. CAN10 has previously shown promising effects in several models of such diseases, including the lead indications systemic sclerosis and myocarditis. Pronounced effects have also been observed in models of psoriasis and these findings will form the basis for studying the effects of CAN10 in psoriasis patients in the phase I trial. Subsequent trials intend to focus on patients with systemic sclerosis or myocarditis.

About Cantargia
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. The main program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia’s second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis.

Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com.

About CAN10
The CAN10 antibody binds strongly to its target IL1RAP and has a unique capability to simultaneously inhibit signaling via IL-1, IL-33 and IL-36. Inhibition of these signals can be of significant value in the treatment of several inflammatory or autoimmune diseases. The initial focus of CAN10 will be on two severe diseases: myocarditis and systemic sclerosis. In preclinical in vivo models of myocarditis, a CAN10 surrogate antibody significantly reduced the development of inflammation and fibrosis, and significantly counteracted the deterioration of the cardiac function. The CAN10 surrogate also inhibited disease development in models of systemic sclerosis, psoriasis, psoriatic arthritis, atherosclerosis and peritonitis. CAN10 is currently evaluated in a phase I clinical trial, with initial data expected in 2024.